Feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial

Background Clinical trials have shown that dexmedetomidine might decrease the occurrence of postoperative delirium after major surgery, but neurosurgical patients were excluded from these studies. We aimed to determine the feasibility of conducting a full-scale randomized controlled trial of the effect of prophylactic low-dose dexmedetomidine on postoperative delirium in patients after elective intracranial operation for brain tumors. Methods In this single-center, parallel-arm pilot randomized controlled trial, adult patients who underwent an elective intracranial operation for brain tumors were recruited. Dexmedetomidine (0.1 μg/kg/hour) or placebo was continuously infused from intensive care unit (ICU) admission on the day of surgery until 08:00 AM on postoperative day one. Adverse events during the study-drug administration were recorded. The primary feasibility endpoint was the occurrence of study-drug interruption. Delirium was assessed twice daily with the Confusion Assessment Method for the ICU during the first five postoperative days. The assessable rate of delirium evaluation was documented. Results Sixty participants were randomly assigned to receive either dexmedetomidine (n = 30) or placebo (n = 30). The study-drug was stopped in two patients (6.7%) in the placebo group due to desaturation after new-onset unconsciousness and an unplanned reoperation for hematoma evacuation and in one patient (3.3%) in the dexmedetomidine group due to unplanned discharge from the ICU. The absolute difference (95% confidence interval) of study-drug interruption between the two groups was 3.3% (− 18.6 to 12.0%), with a noninferiority P value of 0.009. During the study-drug infusion, no bradycardia occurred, and hypotension occurred in one patient (3.3%) in the dexmedetomidine group. Dexmedetomidine tended to decrease the incidence of tachycardia (10.0% vs. 23.3%) and hypertension (3.3% vs. 23.3%). Respiratory depression, desaturation, and unconsciousness occurred in the same patient with study-drug interruption in the placebo group (3.3%). Delirium was evaluated 600 times, of which 590 (98.3%) attempts were assessable except in one patient in the placebo group who remained in a coma after an unplanned reoperation. Conclusions The low rate of study-drug interruption and high assessable rate of delirium evaluation supported a fully powered trial to determine the effectiveness of low-dose dexmedetomidine on postoperative delirium in patients after intracranial operation for brain tumors. Trial registration The trial was registered at ClinicalTrials.gov (NCT04494828) on 31/07/2020.

Feasibility of Low-dose Dexmedetomidine for Prevention of Postoperative Delirium after Intracranial Operations: A Pilot Randomized Controlled Trial

Background: Clinical trials have shown that dexmedetomidine might decrease the occurrence of postoperative delirium after major surgery, but neurosurgical patients were excluded from these studies. We aimed to determine the feasibility of conducting a full-scale randomized controlled trial of the effect of prophylactic low-dose dexmedetomidine on postoperative delirium in patients after elective intracranial operation for brain tumors.Methods: This single-center, parallel-arm pilot randomized controlled trial was conducted in a twenty-bed intensive care unit (ICU) at an academic affiliated hospital. Adult patients who underwent an elective intracranial operation for brain tumors and admitted to the ICU were recruited. Dexmedetomidine (0.1 mg/kg/hour) or placebo was continuously infused from ICU admission on the day of surgery until 08:00 AM on postoperative day one. Adverse events during the study-drug administration were recorded. The primary feasibility endpoint was the occurrence of study-drug interruption. Delirium was assessed twice daily with the Confusion Assessment Method for the ICU during the first five postoperative days. The assessable rate of delirium evaluation was documented.Results: Sixty participants were randomly assigned to receive either dexmedetomidine (n=30) or placebo (n=30). The study-drug was stopped in two patients (6.7%) in the placebo group due to desaturation after new-onset unconsciousness and an unplanned reoperation for hematoma evacuation and in one patient (3.3%) in the dexmedetomidine group due to unplanned discharge from the ICU (P=0.554). During the study-drug infusion, no bradycardia occurred, and hypotension occurred in one patient (3.3%) in the dexmedetomidine group. Dexmedetomidine tended to decrease the incidence of tachycardia (10.0% vs. 23.3%) and hypertension (3.3% vs. 23.3%), but the difference was not statistically significant (P=0.299 and 0.052). Respiratory depression, desaturation, and unconsciousness occurred in the same patient with study-drug interruption in the placebo group (3.3%). Delirium was evaluated 600 times, of which 590 (98.3%) attempts were assessable except in one patient in the placebo group who remained in a coma after an unplanned reoperation.Conclusions: The low rate of study-drug interruption and high assessable rate of delirium evaluation supported a fully powered trial to determine the effectiveness of low-dose dexmedetomidine on postoperative delirium in patients after intracranial operation for brain tumors.Trial registration: The trial was registered at ClinicalTrials.gov (NCT04494828) on July 31, 2020.

Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial

IntroductionPostoperative delirium (POD) is prevalent in patients after major surgery and is associated with adverse outcomes. Several studies have reported that dexmedetomidine, a highly selective α2-adrenergic receptor agonist, can decrease the incidence of POD. However, neurosurgical patients are usually excluded from previous studies. The present study was designed to investigate the impact of prophylactic use of low-dose dexmedetomidine on the incidence of POD in patients after intracranial operation.Methods and analysisThis is a multicentre, randomised, double-blinded and placebo-controlled trial. Seven hundred intensive care unit admitted patients after elective intracranial operation for brain tumours under general anaesthesia are randomly assigned to the dexmedetomidine group or the placebo group with a 1:1 ratio. For patients in the dexmedetomidine group, a continuous infusion of dexmedetomidine will be started at a rate of 0.1 μg/kg/hour immediately after enrolment on the day of operation and continued until 08:00 on postoperative day 1. For patients in the placebo group, normal saline will be administered at the same rate as in the dexmedetomidine group. The patients will be followed up for 28 days after enrolment. The primary endpoint is the incidence of POD, which is assessed two times per day using the Confusion Assessment Method for the intensive care unit (ICU), during the first 5 postoperative days. The secondary endpoints include the incidence of dexmedetomidine-related adverse events and non-delirium complications, the length of stay in the ICU and hospital and all-cause 28-day mortality after the operation.Ethics and disseminationThe study protocol was approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (No KY2019-091-02) and registered at ClinicalTrials.gov. The results of the trial will be presented at national and international conferences relevant to subject fields and submitted to international peer-reviewed journals.Trial registration numberTrial registration number: NCT04399343; Pre-results.

Pneumocephalus after the Treatment of an Inoperable Superior Sulcus Tumor with Chemoradiation

Background. Pneumocephalus is a rare phenomenon that can occur as a complication after operations involving the thoracic discs, following thoracotomy for tumor resection, and after an intracranial operation or cranial trauma. This complication frequently occurs when a tumor is located in the costovertebral angle and an operative intervention creates a tear in the dura resulting in a pleural-dural fistula. Case Presentation. We describe the case of a 58-year-old man with an inoperable superior sulcus tumor who developed pneumocephalus after the initiation of chemoradiation secondary to a pleural-dural fistula. Conclusions. Although a rare occurrence, pneumocephalus should be considered when patients with tumors in the superior sulcus treated with radiation develop neurologic symptoms characteristic of increased intracranial pressure.

Efficacy of dural tenting sutures

Object. The goal of this study was to assess the necessity for the prophylactic use of dural tenting sutures.Methods. Data that had been prospectively collected from 369 consecutive cranial operations in adults were analyzed. In this series of patients, dural tenting sutures were used on a judicious “as needed” basis. They were never used to satisfy a procedural routine or for use as a prophylaxis against epidural hemorrhage that was not apparent. Tenting sutures were used for the control of epidural bleeding in 33 patients (8.9%); no tenting was required in 336 patients (91.1%). Reoperation for postoperative epidural hematoma was not required in this series.Conclusions. Dural tenting sutures continue to have an important role in neurosurgery; however, there is no compelling evidence to support their traditional prophylactic use in every intracranial operation.

Efficacy of dural tenting sutures

Object The goal of this study was to assess the necessity for the prophylactic use of dural tenting sutures. Methods Data that had been prospectively collected from 369 consecutive cranial operations in adults were analyzed. In this series of patients, dural tenting sutures were used on a judicious "as needed" basis. They were never used to satisfy a procedural routine or for use as a prophylaxis against epidural hemorrhage that was not apparent. The sutures were used for the control of epidural bleeding in 33 patients (8.9%); no tenting was required in 336 patients (91.1%). Reoperation for postoperative epidural hematoma was not required in this series. Conclusions Dural tenting sutures continue to have an important role in neurosurgery; however, there is no compelling evidence to support their traditional prophylactic use in every intracranial operation.

Pituitary Adenomas in Childhood and Adolescence

ABSTRACT:Pituitary adenomas are considered rare tumors in the pediatric age group. The natural history in this age group is not well known, although many authors have suggested that pituitary adenomas in children tend to be extrasellar and invasive and that a subfrontal approach is mandatory in the majority. Our patients were part of a surgical series of 356 adenomas of all ages. We have divided these cases into three groups: the first consists of patients operated on before the age of 21 years (52 cases, 15%); the second, patients treated after the age of 20 but in whom the clinical history started before 21 years (52 cases, 15%); the third, patients with surgery and symptoms after 20 years (252 cases, 70%). Transsphenoidal removal of the adenomas was the initial procedure in all but one of these cases; a few required a second intracranial operation. In our series, pituitary adenomas in children were not more invasive than in other age groups.